On October 16, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported a collaboration with the Netherlands Cancer Institute (Stichting Het Nederlands Kanker Instituut (NKI) – Antoni van Leeuwenhoek Ziekenhuis) in Amsterdam to evaluate domatinostat in combination with checkpoint blockade in a "Multicenter Phase 1b Study testing the Neoadjuvant Combination of Domatinostat, Nivolumab, and Ipilimumab, in RECIST 1.1-measurable Stage III Cutaneous or Unknown Primary Melanoma – DONIMI" (Press release, 4SC, OCT 16, 2019, View Source [SID1234542306]).

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Immunotherapy, and particularly checkpoint inhibitors like anti-PD-1 (e.g. Nivolumab) and anti-CTLA4 (Ipilimumab), are increasingly investigated not only in the advanced unresectable or metastatic setting but also in earlier stages of disease. The rationale for such treatment is to activate the immune system before resection of the tumor to generate an immune memory and prevent recurrence of the disease. On the basis of some encouraging data published by the International Neoadjuvant Melanoma Consortium (INMC; View Source), innovative combination approaches will now be tested to optimize the treatment in a more personalized manner where domatinostat is a promising combination partner.

Jason Loveridge, Ph.D., CEO of 4SC: "It is getting clearer and clearer that immunotherapy for cancer is most effective when used early in disease progression and we believe the neoadjuvant setting offers a great potential for protecting patients from recurrence of their malignancy after resection, potentially leading to a much higher number of cured patients with resectable, high-risk melanoma. Prof. Blank and his collaborators within the INMC have already made remarkable progress in this highly innovative field in melanoma and the NKI is a worldwide leading cancer center in the treatment of melanoma and other indications in the neoadjuvant setting. We are grateful entering such collaboration with the NKI and looking forward to the initiation of the DONIMI study in the near future."

Prof. Dr. Christian Blank, NKI: "It is exciting to see what we have achieved with neoadjuvant immunotherapy in melanoma within the INMC during the last few years. However there´s still a way to go to implement a standard neoadjuvant treatment in melanoma. Additional combination approaches to modulate the tumor microenvironment and the patients´ immune system remains a priority so as to optimize and personalize treatment for patients with melanoma, and potentially impact the treatment of patients with other cancers. For example, we do not know yet which patients require double neoadjuvant checkpoint inhibition and who can be treated with neoadjuvant PD-1 blockade alone. Based on preclinical and early clinical data, epigenetic modulation with domatinostat in combination with checkpoint blockade might be a promising approach in the neoadjuvant setting. In the DONIMI study, Domatinostat will be one of the first compounds tested in a personalized neoadjuvant combination trial implemented by INMC researchers from Sydney and Amsterdam. We are much looking forward to enroll the first patients later this year."

On October 16, 2019 Abbott (NYSE: ABT) reported financial results for the third quarter ended Sept. 30, 2019 (Press release, Abbott, OCT 16, 2019, View Source [SID1234542323]).

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Third-quarter worldwide sales of $8.1 billion increased 5.5 percent on a reported basis and 7.6 percent on an organic* basis.
Reported diluted EPS from continuing operations under GAAP was $0.53 in the third quarter. Adjusted diluted EPS from continuing operations, which excludes specified items, was $0.84, an increase of 12.0 percent versus prior year1.
Abbott narrowed its full-year 2019 outlook for diluted EPS from continuing operations on a GAAP basis to $2.06 to $2.08, and full-year adjusted diluted EPS from continuing operations to $3.23 to $3.25, reflecting 12.5 percent growth versus the prior year at the midpoint of the range2.
FreeStyle Libre achieved worldwide sales of $496 million in the quarter, an increase of 63.1 percent on a reported basis and 67.6 percent on an organic basis versus the prior year.
During the third quarter, FreeStyle Libre obtained public reimbursement coverage in Ontario and Quebec, becoming the first and only sensor-based glucose monitoring system to be listed by any provincial health plan in Canada.
Worldwide sales of MitraClip were $176 million in the quarter, an increase of 30.4 percent on a reported basis and 31.9 percent on an organic basis, including U.S. growth of 45.7 percent versus the prior year. During the third quarter, Abbott announced U.S. FDA approval of its next-generation MitraClip device, which offers enhancements and more sizes to offer doctors further options.
In September, Abbott announced data from its COAPT Trial that shows that MitraClip is projected to increase life-expectancy and quality of life compared to guideline-directed medical therapy alone in heart failure patients with secondary mitral regurgitation, or a leaky mitral heart valve.
During the third quarter, Abbott received U.S. FDA approval for its Alinity-S diagnostics system, the latest technology for screening and protecting the U.S. blood and plasma supply.
"We’re performing exceptionally well across several areas," said Miles D. White, chairman and chief executive officer, Abbott. "We’re right on track to achieve ongoing EPS and organic sales growth at the upper-end of our initial guidance ranges for the year."

* See note on organic growth below.

THIRD-QUARTER BUSINESS OVERVIEW
Note: Management believes that measuring sales growth rates on an organic basis is an appropriate way for investors to best understand the underlying performance of the business.

Organic sales growth:

Excludes the prior year first, second and third-quarter results for a non-core business within U.S. Adult Nutrition, which was discontinued during the third quarter 2018; and
Excludes the impact of foreign exchange.

Third-quarter 2019 worldwide sales of $8.1 billion increased 5.5 percent on a reported basis. On an organic basis, worldwide sales increased 7.6 percent. Refer to tables titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Worldwide Nutrition sales increased 2.0 percent on a reported basis in the third quarter. On an organic basis, sales increased 3.8 percent. Refer to tables titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Worldwide Pediatric Nutrition sales increased 0.5 percent on a reported basis in the third quarter, including an unfavorable 0.9 percent effect of foreign exchange, and increased 1.4 percent on an organic basis. In the U.S., sales growth was led by Abbott’s market-leading toddler brands, PediaSure and Pedialyte. International sales declined 2.4 percent on a reported basis and 0.7 percent on an organic basis, driven by challenging market dynamics in Greater China, partially offset by growth across several countries in Southeast Asia and Latin America.

Worldwide Adult Nutrition sales increased 3.9 percent on a reported basis in the third quarter and increased 6.9 percent on an organic basis. International Adult Nutrition sales increased 7.5 percent on a reported basis and 10.4 percent on an organic basis in the third quarter. Sales performance in the quarter was led by strong growth of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading diabetes-specific nutrition brand.

Worldwide Diagnostics sales increased 4.7 percent on a reported basis in the third quarter, including an unfavorable 1.9 percent effect of foreign exchange, and increased 6.6 percent on an organic basis.

Core Laboratory Diagnostics sales increased 8.3 percent on a reported basis and 10.6 percent on an organic basis in the third quarter. Sales performance was led by above-market growth in the U.S. and internationally, where Abbott is achieving continued strong adoption of its Alinity family of innovative and highly differentiated diagnostic instruments. During the third quarter, Abbott received U.S. FDA approval for its Alinity-S blood and plasma screening diagnostics instrument and several testing assays.

Molecular Diagnostics sales decreased 7.8 percent on a reported basis in the third quarter, including an unfavorable 1.4 percent effect of foreign exchange, and decreased 6.4 percent on an organic basis. Internationally, sales growth in the quarter was negatively impacted by lower non-governmental organization purchases in Africa.

Point of Care Diagnostics sales increased 6.3 percent on a reported basis in the third quarter, including an unfavorable 0.4 percent effect of foreign exchange, and increased 6.7 percent on an organic basis. Sales growth was led by Abbott’s market-leading i-STAT handheld system in the U.S. and internationally.

Rapid Diagnostics sales decreased 0.7 percent on a reported basis in the third quarter, including an unfavorable 1.5 percent effect of foreign exchange, and increased 0.8 percent on an organic basis. Organic sales growth was led by infectious disease testing in developed markets and cardio-metabolic testing globally, partially offset by lower than expected infectious disease testing sales in Africa.

Established Pharmaceuticals sales increased 4.4 percent on a reported basis in the third quarter, including an unfavorable 3.5 percent effect of foreign exchange, and increased 7.9 percent on an organic basis.

Key Emerging Markets include India, Brazil, Russia and China along with several additional emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies increased 2.8 percent on a reported basis in the third quarter and increased 6.8 percent on an organic basis, which excludes an unfavorable 4.0 percent effect of foreign exchange. Organic sales growth was led by strong growth across several geographies, including India, China and Brazil.

Other sales increased 9.2 percent on a reported basis in the third quarter, including an unfavorable 1.7 percent effect of foreign exchange, and increased 10.9 percent on an organic basis.

Worldwide Medical Devices sales increased 8.9 percent on a reported basis in the third quarter and increased 10.6 percent on an organic basis, led by double-digit growth in Electrophysiology, Heart Failure, Structural Heart and Diabetes Care.

In Electrophysiology, growth was led by strong performance in cardiac diagnostic and ablation catheters, which are used to help physicians accurately and effectively treat atrial fibrillation, a form of irregular heartbeat.

In Heart Failure, strong double-digit growth was driven by market adoption of Abbott’s HeartMate 3 left ventricular assist device, which has been shown to improve survival and clinical outcomes in patients with advanced heart failure.

Growth in Structural Heart was led by MitraClip, Abbott’s market-leading device for the minimally invasive treatment of mitral regurgitation, or a leaky mitral heart valve. In the third quarter, Abbott announced U.S. FDA approval of its next-generation MitraClip device, MitraClip G4, which offers an expanded range of clip sizes, an alternative leaflet grasping feature and facilitation of procedure assessment in real time to offer doctors further options when treating mitral valve disease.

In Diabetes Care, sales increased 29.6 percent on a reported basis and 33.1 percent on an organic basis in the third quarter. Sales growth in the quarter was led by FreeStyle Libre, Abbott’s revolutionary continuous glucose monitoring system, with worldwide sales of $496 million, an increase of 63.1 percent on a reported basis and 67.6 percent on an organic basis versus the prior year. During the third quarter, FreeStyle Libre obtained public reimbursement coverage in Ontario and Quebec, becoming the first and only sensor-based glucose monitoring system to be listed by any provincial health plan in Canada.

ABBOTT’S GUIDANCE FOR 2019
Abbott is narrowing its guidance for 2019 diluted earnings per share from continuing operations under Generally Accepted Accounting Principles (GAAP) to $2.06 to $2.08. Abbott forecasts net specified items for the full year 2019 of $1.17 per share. Specified items include intangible amortization expense, acquisition-related expenses, charges associated with cost reduction initiatives and other expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $3.23 to $3.25 for the full year 2019.

Abbott is issuing fourth-quarter 2019 guidance for diluted earnings per share from continuing operations under GAAP of $0.59 to $0.61. Abbott forecasts specified items for the fourth quarter 2019 of $0.35 per share primarily related to intangible amortization, acquisition-related expenses, cost reduction initiatives and other expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $0.94 to $0.96 for the fourth quarter.

ABBOTT DECLARES 383RD CONSECUTIVE QUARTERLY DIVIDEND
On Sept. 12, 2019, the board of directors of Abbott declared the company’s quarterly dividend of $0.32 per share. Abbott’s cash dividend is payable Nov. 15, 2019, to shareholders of record at the close of business on Oct. 15, 2019.

Abbott has increased its dividend payout for 47 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

On October 16, 2019 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized chimeric antigen receptor T cell ("CAR T") platform technology engineered to target patient-specific tumor neoantigens, reported that Jeffrey Eisenberg, Chief Executive Officer of Xenetic, will present at BIO Investor Forum on Wednesday, October 23, 2019 at 2:45 PM PT in San Francisco, CA (Press release, Xenetic Biosciences, OCT 16, 2019, View Source [SID1234542307]).

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As part of his presentation, Mr. Eisenberg will provide a Company overview and discuss the Company’s novel CAR T platform technology, called "XCART," a proximity-based screening platform capable of identifying CAR constructs that can target patient-specific tumor neoantigens, with a demonstrated proof of mechanism in B-cell Non-Hodgkin lymphomas. Xenetic is currently advancing the development program for XCART to confirm the positive preclinical results shown to date and to demonstrate a more attractive safety profile than existing therapies.

In addition to the presentation, management will also be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference.

A live audio webcast of the presentation will be available on the IR Calendar in the Investors section of Xenetic’s website (www.xeneticbio.com) or by accessing the conference website here. Within three days of the event, a webcast replay will be made available on the Company’s website.

About BIO Investor Forum

Now in its 17th year, the BIO Investor Forum is an international biotech investor conference focused on early and established private companies as well as emerging public companies. The event features plenary sessions, business roundtables, therapeutic workshops, company presentations, and BIO One-on-One Partnering meetings. For more information, please visit the conference website here.

On October 16, 2019 CryoLife, Inc. (NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease, reported that 2019 third quarter financial results will be released on Wednesday, October 30, 2019 after the market closes (Press release, CryoLife, OCT 16, 2019, View Source [SID1234542324]). On that day, the Company will hold a teleconference call and live webcast at 5:30 p.m. ET to discuss the results, followed by a question and answer session hosted by Pat Mackin, Chairman, President and Chief Executive Officer of CryoLife, Inc.

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To listen to the live teleconference, please dial 201-689-8261 a few minutes prior to 5:30 p.m. ET. A replay of the teleconference will be available October 30 through November 6 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415. The conference number for the replay is 13695440.

The live webcast and replay can be accessed in the Investor Relations section of the CryoLife website at www.cryolife.com and selecting Webcasts & Presentations. In addition, a copy of the earnings press release, which will contain financial and statistical information for the completed quarter and full year, can be accessed in the Investor Relations section of the CryoLife website.

On October 16, 2019 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions in skin cancers and uveal melanoma, reported the presentation of a multicenter, prospective study demonstrating that DecisionDx-UM test results significantly impacted treatment plan recommendations for patients with uveal melanoma (Press release, Castle Biosciences, OCT 16, 2019, View Source [SID1234542308]). The study was presented at the American Academy of Ophthalmology 2019 Annual Meeting held October 12-15, 2019, in San Francisco.

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The CLEAR II study (Clinical Application of DecisionDx-UM Gene Expression Assay Results) was designed to prospectively evaluate metastatic surveillance regimens for patients with uveal melanoma who were tested with the DecisionDx-UM gene expression profile (GEP) test as part of their diagnostic work-up.

"Treatment planning in uveal melanoma is critical since 30% of patients who are diagnosed with uveal melanoma will experience life-threatening metastasis within five years despite successful control of the primary tumor," commented study co-author and presenter Amy C. Schefler, M.D., Associate Professor of Clinical Ophthalmology, Weill Cornell Medical College/Houston Methodist Hospital and the University of Texas Health Science Center at Houston, and Retina Consultants of Houston. "The results from the CLEAR II study demonstrate that the DecisionDx-UM test has a significant impact on treatment planning, helping to ensure that patients receive imaging, follow-up and referrals that are appropriate for their individual risk."

Study Highlights:

138 patients from eight centers were enrolled between March 2018 and February 2019.
93 patients (67%) had a low-risk Class 1 test result; 45 patients (33%) had a high-risk Class 2 test result.
Results showed that patients with a Class 2 DecisionDx-UM result were significantly more often followed by medical oncology for surveillance compared to ocular oncology or primary care physicians (p=0.002).
95% (42 of 44) of the Class 2 patients who received a referral were referred to medical oncology.
Patients with a Class 2 result were significantly more likely to receive recommendations for frequent (three or four times a year) abdominal imaging, chest imaging, and liver function testing compared to Class 1 patients (p<0.0001).
These findings show that treatment plan recommendations are aligned with metastatic risk and consistent with results from previously published studies documenting the impact of DecisionDx-UM on patient management.